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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO CORPORATION (WEIHAI) NIPRO SYRINGE WITH NEEDLE

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NIPRO CORPORATION (WEIHAI) NIPRO SYRINGE WITH NEEDLE Back to Search Results
Model Number JD+10L2025-WEI
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
Final investigation on returned unused samples pending.
 
Event Description
On 3 different occasions, the center part of the luer lock was broken off into the venous needle on the patient's access, after heparin administration, prior to initiating the treatment. On 2 of those incidents, they needed to recannulate the patients in order for them to perform the treatment. Staff stated that all of these incidents happened during week, but did not have exact dates. There have been no further incidents reported. No medical interventions or serious injuries were noted by the staff.
 
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Brand NameNIPRO SYRINGE WITH NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
Manufacturer (Section D)
NIPRO CORPORATION (WEIHAI)
20 xingshan road
hight tech industrial developm
weihai
CH
MDR Report Key7239332
MDR Text Key98970870
Report Number1056186-2018-00003
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 02/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJD+10L2025-WEI
Device Lot Number20170405
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/02/2018
Distributor Facility Aware Date01/04/2018
Device Age8 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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